Ademetionine in Obstructive Hypertrophic Cardiomyopathy

NCT07367724 | Recruiting Phase 2

• 1 other identifier: 2025-ZX068
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 3

Brief Summary

This study is a multicenter, double-blind, randomized controlled Phase 2 trial designed to evaluate the safety and efficacy of Ademetionine in patients with obstructive hypertrophic cardiomyopathy (oHCM). The study will recruit patients with oHCM who, under double-blind conditions, will be randomly assigned to either the Ademetionine group or the placebo group. Follow-up visits will be conducted every 4 weeks until 16 weeks from baseline. After 16 weeks, the study will evaluating the effect of Ademetionine on exercise capacity, heart failure symptoms, cardiac structure and function, and quality of life, as well as safety and tolerability of Ademetionine in this patient population.

Conditions

Obstructive Hypertrophic Cardiomyopathy (oHCM)

Outcome Measures

Primary Outcomes (1)

• Change in pVO₂ by CPET from baseline to Week 16

  From enrollment to the end of treatment at 16 weeks

Secondary Outcomes (7)

• Proportion of participants with ≥1 class improvement in NYHA Functional Class from baseline to Week 16

  From enrollment to the end of treatment at 16 weeks

• Change in KCCQ-CSS from baseline to Week 16

  From enrollment to the end of treatment at 16 weeks

• Change in provoked left ventricular outflow tract gradient from baseline to Week 16

  From enrollment to the end of treatment at 16 weeks

• Change in left ventricular mass index from baseline to Week 16

  From enrollment to the end of treatment at 16 weeks

• Change in left atrial volume index from baseline to Week 16

  From enrollment to the end of treatment at 16 weeks

Other Outcomes (6)

• Change in maximal left ventricular wall thickness from baseline to Week 16

  From enrollment to the end of treatment at 16 weeks

• Change in NT-proBNP from baseline to Week 16

  From enrollment to the end of treatment at 16 weeks

• Change in hs-cTnI from baseline to Week 16

  From enrollment to the end of treatment at 16 weeks

Study Arms (2)

Ademetionine group

ACTIVE COMPARATOR

Drug: Ademetionine 1,4-Butanedisulfonate

Placebo group

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Ademetionine 1,4-Butanedisulfonate DRUG

Ademetionine 1,4-Butanedisulfonate is the currently available marketed oral pharmaceutical formulation of S-adenosylmethionine. Its brand name is Ximeixin in China.

Ademetionine group

Placebo DRUG

The placebo is a starch tablet identical in appearance, odor, and other physical properties.

Placebo group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Meet the diagnostic criteria for HCM.
• Age ≥ 18 years at screening.
• LVEF ≥ 50% at screening.
• Echocardiography demonstrates a resting or provoked LVOTG ≥ 30 mmHg at screening.
• NYHA Functional Class II-III at screening.
• Able to perform CPET.
• Patients receiving treatment with β-blockers or non-dihydropyridine calcium channel blockers should have been on a stable dose for at least 6 weeks prior to randomization and are expected to maintain the same medication during the trial. Who have previously received cardiac myosin inhibitors (e.g., Mavacamten) must discontinue the treatment for at least 8 weeks prior to randomization.
• Willing and able to sign the informed consent form and comply with all scheduled study visits.

You may not qualify if:

• History of severe hypersensitivity to any component of Ademetionine 1,4-Butanedisulfonate Enteric-coated Tablets.
• History of psychiatric disorders, or current use of antidepressants such as clomipramine.
• Planned for any surgical (including septal reduction therapy) or interventional procedure during the trial period.
• Planned use of cardiac myosin inhibitors (e.g., Mavacamten) during the trial period.
• Currently pregnant or planning pregnancy.
• Currently participation in another drug or device clinical trial.
• History of any other disease with a life expectancy of less than 1 year.

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases: lead

Study Sites (3)

Fuwai Hospital

Beijing, China

RECRUITING

Zhongshan Hospital, Shanghai Medical College of Fudan University

Shanghai, China

RECRUITING

The First Affiliated Hospital of Xinjiang Medical University

Xinjiang, China

NOT YET RECRUITING

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases

Central Study Contacts

Yu Zhang

CONTACT

+86 19801288531; dr_yuzhang@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 25, 2025
• First Posted: January 26, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 20, 2026

Record last verified: 2026-03

Locations

CN (3)